The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Toplock Anchor System.
| Device ID | K193377 |
| 510k Number | K193377 |
| Device Name: | TopLock Anchor System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Fusion Orthopedics, LLC 4135 S. Power Rd. Suite 110 Mesa, AZ 85212 |
| Contact | Kolby Black |
| Correspondent | Kolby Black Fusion Orthopedics, LLC 4135 S. Power Rd. Suite 110 Mesa, AZ 85212 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-05 |
| Decision Date | 2020-11-25 |